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    Home > Medical News > Latest Medical News > Tapentadol, a subsidiary of Renfu Pharmaceutical Holdings, obtained the tentative approval number of the US FDA

    Tapentadol, a subsidiary of Renfu Pharmaceutical Holdings, obtained the tentative approval number of the US FDA

    • Last Update: 2022-05-13
    • Source: Internet
    • Author: User
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    On May 5, Humanwell Pharmaceutical announced that its holding subsidiary Humanwell Pharmaceutical US, Inc.
    (referred to as "Yichang Humanwell Pharmaceutical US Company") received the tentative approval number for tapentadol from the US FDA.


    Tapentadol tablets are used to treat acute pain
    Yichang Renfu Pharmaceutical USA submitted an ANDA application for tapentadol in 2020, with a cumulative R&D investment of approximately RMB 15 million

    According to IQVIA statistics, the total sales of the drug (original drug) in the U.
    market in 2021 will be approximately US$190 million.
    The original drug belongs to Collegium, and manufacturers that have received tentative approval include Actavis, Alkem, Roxane, and Rhodes

    There is currently no tapentadol in the domestic market.
    Anhui Xinxing Drug Development Co.
    , Ltd.
    , Jiangsu Enhua Pharmaceutical Co.
    , Ltd.
    , Jiangsu Huatai Chenguang Pharmaceutical Co.
    , Ltd.
    and the company's holding subsidiary Yichang Renfu Pharmaceutical Co.
    , Ltd.
    Conduct clinical studies of tapentadol tablets


    Currently, Collegium holds two patents for tapentadol, with expiration dates on August 5, 2022 and June 27, 2025, respectively
    After the above patents expire and are officially approved, Yichang Renfu Pharmaceutical US Company can market the tapentadulo tablets that have obtained the ANDA approval number this time


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